A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

• Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

• Drug: aleglitazar
  150 mcg orally daily
• Drug: Placebo
  matching aleglitazar placebo tablet orally daily

• Experimental: Aleglitazar
  Intervention: Drug: aleglitazar
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
• Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

• Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

• Current treatment with a thiazolidinedione (TDZ) or fibrate
• Prior intolerance to a TDZ or fibrate
• Previous participation in a trial with aleglitazar
• Other types of diabetes
• Inadequate liver, hematologic or renal function
• Symptomatic heart failure classified as NYHA class II-IV
• Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
• Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
• History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
• Currently scheduled for arterial revascularization procedures
• Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
• Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years